FDAFDA · Food and drugs·Recall number D-1169-2014
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Published March 26, 2014 · Recall initiated: June 27, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Fabscout Entertainment, Inc
- Distributor
- Nationwide and France
- Lot
- All lots
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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